This is an international site for VOTUBIA® (everolimus) and is intended for Health Care Professionals in the EU. The information on this site is based on the EU SmPC and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country via www.novartisoncology.com/contactus.

This medicinal product has been authorized under a so-called, conditional approvalTM scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on the product every year and the EU SmPC will be updated as necessary.

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Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)

VOTUBIA® is indicated for the treatment of adult patients with renal angiomyolipoma with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size, presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.

The evidence is based on analysis of change in sum of angiomyolipoma volume.

Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)

VOTUBIA® is indicated for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.

The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.

Reference

  1. VOTUBIA® [summary of product characteristics]. Novartis Pharma AG; 2013.

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